Prospective Grant of Exclusive License: Orally Active Synthetic Estrogens for Fertility Control, Hormone Replacement Therapy, and Endometriosis, 14575 [E9-7210]
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Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Technology Transfer on or before June
1, 2009 will be considered.
National Institutes of Health
ADDRESSES:
Requests for copies of the
patents, inquiries, comments, and other
materials relating to the contemplated
license should be directed to: Tara L.
Kirby, Ph.D., Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
301–435–4426; Facsimile: 301–402–
0220; E-mail: tarak@mail.nih.gov.
Prospective Grant of Exclusive
License: Orally Active Synthetic
Estrogens for Fertility Control,
Hormone Replacement Therapy, and
Endometriosis
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(1), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the invention
embodied in United States Patent No.
5,554,603, issued September 10, 1996,
entitled ‘‘Orally Active Derivatives of 1,
3, 5(10)–Estratriene’’ (HHS Ref. No. E–
137–1993/0–US–01); PCT Application
No. PCT/US94/10393, filed September
15, 1994, now expired, entitled ‘‘Orally
Active Derivatives of 1, 3, 5(10)–
Estratriene’’ (HHS Ref. No. E–137–1993/
0–PCT–02); Australian Patent No.
700576, issued April 22, 1999, entitled
‘‘Orally Active Derivatives of 1, 3,
5(10)–Estratriene’’ (HHS Ref. No. E–
137–1993/0–AU–03); Canadian Patent
No. 2171740, issued July 26, 2005,
entitled ‘‘Orally Active Derivatives of 1,
3, 5(10)–Estratriene’’ (HHS Ref. No. E–
137–1993/0–CA–04); European Patent
No. 719276, issued November 26, 1997,
entitled ‘‘Orally Active Derivatives of 1,
3, 5(10)–Estratriene’’ (HHS Ref. No. E–
137–1993/0–EP–05) and validated in
Austria, Switzerland, Germany,
Denmark, Spain, France, Greece,
Ireland, Italy, Luxembourg, Monaco, the
Netherlands, Portugal, Sweden,
Belgium, and Great Britain; and
Japanese Patent No. 3993228, issued
August 3, 2007, entitled ‘‘Orally Active
Derivatives of 1, 3, 5(10)–Estratriene’’
(HHS Ref. No. E–137–1993/0–JP–06) to
Evestra, Inc., having a place of business
in San Antonio, Texas. The patent rights
in this invention have been assigned to
the United States of America.
The contemplated exclusive license
territory may be worldwide, and the
field of use may be limited to the use
of CDB–3701 (11b, 17b–
dinitratoestradiol 3-acetate) for all
indications where estrogen is prescribed
as a treatment, including fertility
control, hormone replacement therapy
(‘‘HRT’’), and endometriosis.
DATES: Only written comments and/or
application for a license which are
received by the NIH Office of
tjames on PRODPC61 with NOTICES
SUMMARY:
VerDate Nov<24>2008
14:35 Mar 30, 2009
Jkt 217001
The utility
of estrogenic substances in the practice
of medicine is well documented.
Estrogens may be used for the
replacement of the natural hormone
estradiol in hypogonadism, and
following the removal of the ovaries or
cessation of ovarian activity during
menopause. They are also widely
employed as a component of oral
contraceptives. However, available
orally-active synthetic estrogens are
associated with a number of potential
side effects, including cancer, blood
clots, heart attack, elevated blood
pressure, and reduced glucose tolerance.
This technology relates to a family of
novel, active estrogens that are nitrate
esters of estradiol. These nitrate esters
possess enhanced estrogenic activity
following oral administration and lack a
17-ethynyl alcohol, which has been
implicated in many side effects
attributed to other synthetic estrogens. It
is anticipated that these esters could be
used in all instances where estrogen is
prescribed as a treatment.
The prospective exclusive license will
be royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 60 days from the date of this
published Notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the
prospective field of use filed in response
to this notice will be treated as
objections to the grant of the
contemplated exclusive license.
Comments and objections submitted in
response to this notice will not be made
available for public inspection, and, to
the extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
14575
Dated: March 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–7210 Filed 3–30–09; 8:45 am]
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E:\FR\FM\31MRN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Notices]
[Page 14575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7210]
[[Page 14575]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Orally Active Synthetic
Estrogens for Fertility Control, Hormone Replacement Therapy, and
Endometriosis
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(1), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to practice the invention embodied in
United States Patent No. 5,554,603, issued September 10, 1996, entitled
``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No.
E-137-1993/0-US-01); PCT Application No. PCT/US94/10393, filed
September 15, 1994, now expired, entitled ``Orally Active Derivatives
of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-PCT-02);
Australian Patent No. 700576, issued April 22, 1999, entitled ``Orally
Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-
1993/0-AU-03); Canadian Patent No. 2171740, issued July 26, 2005,
entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS
Ref. No. E-137-1993/0-CA-04); European Patent No. 719276, issued
November 26, 1997, entitled ``Orally Active Derivatives of 1, 3, 5(10)-
Estratriene'' (HHS Ref. No. E-137-1993/0-EP-05) and validated in
Austria, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland,
Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, Belgium,
and Great Britain; and Japanese Patent No. 3993228, issued August 3,
2007, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene''
(HHS Ref. No. E-137-1993/0-JP-06) to Evestra, Inc., having a place of
business in San Antonio, Texas. The patent rights in this invention
have been assigned to the United States of America.
The contemplated exclusive license territory may be worldwide, and
the field of use may be limited to the use of CDB-3701 (11[beta],
17[beta]-dinitratoestradiol 3-acetate) for all indications where
estrogen is prescribed as a treatment, including fertility control,
hormone replacement therapy (``HRT''), and endometriosis.
DATES: Only written comments and/or application for a license which are
received by the NIH Office of Technology Transfer on or before June 1,
2009 will be considered.
ADDRESSES: Requests for copies of the patents, inquiries, comments, and
other materials relating to the contemplated license should be directed
to: Tara L. Kirby, Ph.D., Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; E-mail: tarak@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The utility of estrogenic substances in the
practice of medicine is well documented. Estrogens may be used for the
replacement of the natural hormone estradiol in hypogonadism, and
following the removal of the ovaries or cessation of ovarian activity
during menopause. They are also widely employed as a component of oral
contraceptives. However, available orally-active synthetic estrogens
are associated with a number of potential side effects, including
cancer, blood clots, heart attack, elevated blood pressure, and reduced
glucose tolerance.
This technology relates to a family of novel, active estrogens that
are nitrate esters of estradiol. These nitrate esters possess enhanced
estrogenic activity following oral administration and lack a 17-ethynyl
alcohol, which has been implicated in many side effects attributed to
other synthetic estrogens. It is anticipated that these esters could be
used in all instances where estrogen is prescribed as a treatment.
The prospective exclusive license will be royalty-bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless, within 60 days
from the date of this published Notice, the NIH receives written
evidence and argument that establishes that the grant of the license
would not be consistent with the requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the prospective field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive license. Comments and objections submitted
in response to this notice will not be made available for public
inspection, and, to the extent permitted by law, will not be released
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: March 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-7210 Filed 3-30-09; 8:45 am]
BILLING CODE 4140-01-P
